ACTIVE: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

• Sponsor: Radius Health, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01343004
• Collaborator: (none)
• Enrollment: 2,463
• Locations: 28
• Arms: 3
• Duration (Months): 42
• Patients Per Site: 88
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Postmenopausal Osteoporosis	Drug: Placebo; Drug: BA058 80 mcg; Drug: teriparatide	Phase 3

Detailed Description

This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2463 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo identical in appearance to BA058 study drug	Drug: Placebo; Placebo 0 mcg subcutaneous daily
Experimental: BA058 80 mcg (abaloparatide)	Drug: BA058 80 mcg; BA058 80 mcg subcutaneous daily; Other Names: abaloparatide, Abaloparatide-SC
Active Comparator: teriparatide Blinded until after randomization, then open-label	Drug: teriparatide; teriparatide 20 mcg subcutaneous daily; Other Names: Forteo Forsteo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With New Vertebral Fractures at 18 Months [18 months]

Secondary Outcome Measures

1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months [Basline and 18 months]

2. Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18 [Baseline and 18 months]

3. Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18 [Baseline and 18 months]

4. Number of Participants With Non-vertebral Fractures at 18 Months [18 months]

5. Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis

• The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0

• Normal physical exam, vital signs, electrocardiogram (ECG) and medical history

• Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

• History of more than 4 mild or moderate spine fractures or any severe fracture

• Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)

• Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)

• History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient

• Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)

• Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)

• Prior treatment with an investigational drug within the past 12 months

• History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lakewood	Colorado	United States
2		Miami	Florida	United States
3		N. Miami	Florida	United States
4		Atlanta	Georgia	United States
5		Bethesda	Maryland	United States
6		Buenos Aires		Argentina
7		Brasilia		Brazil
8		Curitiba		Brazil
9		Rio de Janeiro		Brazil
10		Sao Paolo		Brazil
11		Vitoria		Brazil
12		Brno		Czech Republic
13		Pardubice		Czech Republic
14		Prague		Czech Republic
15		Aalborg		Denmark
16		Ballerup		Denmark
17		Vejle		Denmark
18		Tallinn		Estonia
19		Tartu		Estonia
20		Hong Kong		Hong Kong
21		Vilnius		Lithuania
22		Bialystok		Poland
23		Katowice		Poland
24		Kielce		Poland
25		Lodz		Poland
26		Warszaw		Poland
27		Zgierz		Poland
28		Bucharest		Romania

Sponsors and Collaborators

• Radius Health, Inc.

Investigators

• Study Director: Radius Health, Inc., Radius Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radius Health, Inc.
• ClinicalTrials.gov Identifier: NCT01343004
• Other Study ID Numbers: BA058-05-003; ACTIVE Trial
• First Posted: Apr 27, 2011
• Last Update Posted: Mar 1, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Radius Health, Inc.: BA058; abaloparatide; Abaloparatide-SC; osteoporosis; postmenopausal; bone loss; ACTIVE; fracture
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Teriparatide; Abaloparatide

Study Results

Participant Flow

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Period Title: Overall Study
STARTED	821	824	818
COMPLETED	637	606	658
NOT COMPLETED	184	218	160

Baseline Characteristics

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide	Total
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily	Total of all reporting groups
Overall Participants	821	824	818	2463
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.7 (6.5)	68.9 (6.5)	68.8 (6.6)	68.8 (6.5)
Gender (Count of Participants)
Female	821 100%	824 100%	818 100%	2463 100%
Male	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With New Vertebral Fractures at 18 Months
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	711	690	717
Number [participants]	30 3.7%	4 0.5%	6 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BA058 80 mcg (Abaloparatide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Time Frame	Basline and 18 months

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	821	823	818
Mean (Standard Deviation) [percent change from baseline]	0.48 (3.82)	9.20 (7.54)	9.12 (6.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BA058 80 mcg (Abaloparatide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	BA058 80 mcg (Abaloparatide), Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8155
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

3. Secondary Outcome

Title	Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
Time Frame	Baseline and 18 months

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	820	822	818
Mean (Standard Deviation) [percent change]	-0.08 (2.77)	3.44 (3.51)	2.81 (3.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BA058 80 mcg (Abaloparatide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	BA058 80 mcg (Abaloparatide), Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

4. Secondary Outcome

Title	Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
Time Frame	Baseline and 18 months

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	820	822	818
Mean (Standard Deviation) [percent change]	-0.44 (3.57)	2.90 (4.21)	2.26 (3.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BA058 80 mcg (Abaloparatide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	BA058 80 mcg (Abaloparatide), Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	ANCOVA
	Comments	P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.

5. Secondary Outcome

Title	Number of Participants With Non-vertebral Fractures at 18 Months
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	821	824	818
Number [Participants]	33 4%	18 2.2%	24 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BA058 80 mcg (Abaloparatide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0318
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2304
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	BA058 80 mcg (Abaloparatide), Teriparatide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3361
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Safety population included all patients who received 1 or more doses of study medication

Arm/Group Title	Placebo	BA058 80 mcg (Abaloparatide)	Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily	BA058 80 mcg: BA058 80 mcg subcutaneous daily	Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
Measure Participants	820	822	818
Number [Hypercalcemic events]	5	15	34

Adverse Events

Arm/Group Title	Placebo		BA058 80 mcg (Abaloparatide)		Teriparatide
Arm/Group Description	Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily		BA058 80 mcg: BA058 80 mcg subcutaneous daily		Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily
All Cause Mortality
	Placebo		BA058 80 mcg (Abaloparatide)		Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		BA058 80 mcg (Abaloparatide)		Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/820 (11%)		80/822 (9.7%)		82/818 (10%)
Blood and lymphatic system disorders
Anaemia	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Cardiac disorders
Myocardial ischaemia	0/820 (0%)		2/822 (0.2%)		1/818 (0.1%)
Supraventricular tachycardia	0/820 (0%)		2/822 (0.2%)		1/818 (0.1%)
Atrioventricular block	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Cardio-respiratory arrest	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Myocardial infraction	2/820 (0.2%)		1/822 (0.1%)		0/818 (0%)
Palpitations	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Acute coronary syndrome	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Acute myocardial infarction	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Angina pectoris	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Angina unstable	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Atrial fibrillation	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Cardiac failure congestive	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Cardiomyopathy	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Coronary artery stenosis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Mitral valve stenosis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Sinus bradycardia	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Ear and labyrinth disorders
Vertigo	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Vestibular disorder	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Endocrine disorders
Goitre	1/820 (0.1%)		1/822 (0.1%)		2/818 (0.2%)
Thyroid cyst	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Eye disorders
Malculopathy	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Retinal artery occulusion	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Cataract	2/820 (0.2%)		0/822 (0%)		1/818 (0.1%)
Gastrointestinal disorders
Gastric Ulcer	0/820 (0%)		2/822 (0.2%)		1/818 (0.1%)
Abdominal pain	3/820 (0.4%)		1/822 (0.1%)		0/818 (0%)
Colitis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Constipation	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Duodenal ulcer	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Haemorrhoids	1/820 (0.1%)		1/822 (0.1%)		1/818 (0.1%)
Intestinal obstruction	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Pancreatitis acute	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Vomiting	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Change of bowel habit	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Diverticulum	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Enterocele	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Gastric haemorrhage	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Gastritis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Gastrointestinal haemorrhage	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Inguinal hernia	2/820 (0.2%)		0/822 (0%)		0/818 (0%)
Large intestine polyp	2/820 (0.2%)		0/822 (0%)		0/818 (0%)
General disorders
Chest pain	2/820 (0.2%)		1/822 (0.1%)		1/818 (0.1%)
Pyrexia	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Chest discomfort	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
General physical health deterioration	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Sudden death	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Hepatobiliary disorders
Cholelithiasis	0/820 (0%)		3/822 (0.4%)		1/818 (0.1%)
Cholangitis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Bile duct stenosis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Biliary dyskinesia	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Cholecystitis acute	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Infections and infestations
Sepsis	0/820 (0%)		2/822 (0.2%)		0/818 (0%)
Urinary tract infection	1/820 (0.1%)		2/822 (0.2%)		0/818 (0%)
Appendicitis	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Bronchiolitis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Bronchitis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Bronchopneumonia	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Influenza	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Pneumonia	1/820 (0.1%)		1/822 (0.1%)		1/818 (0.1%)
Bacterial infection	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Dengue fever	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Gastroenteritis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Helicobacter infection	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Localised infection	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Nasopharyngitis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Paronychia	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Pyelonephritis acute	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Respiratory tract infection	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Viral infection	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Injury, poisoning and procedural complications
Craniocerebral injury	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Fibula fracture	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Humerus fracture	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Incisional hernia	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Joint dislocation	2/820 (0.2%)		1/822 (0.1%)		0/818 (0%)
Ligament rupture	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Patella fracture	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Postoperative hernia	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Spinal compression fracture	0/820 (0%)		1/822 (0.1%)		2/818 (0.2%)
Upper limb fracture	2/820 (0.2%)		1/822 (0.1%)		1/818 (0.1%)
Ankle fracture	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Contusion	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Extradural haematoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Femur fracture	3/820 (0.4%)		0/822 (0%)		0/818 (0%)
Fracture displacement	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Hand fracture	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Lower limb fracture	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Lumbar vertebral fracture	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Meniscus injury	3/820 (0.4%)		0/822 (0%)		2/818 (0.2%)
Pelvic fracture	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Radius fracture	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Tibia fracture	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Ulna fracture	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Wrist fracture	0/820 (0%)		0/822 (0%)		2/818 (0.2%)
Investigations
Weight decreased	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Blood glucose increased	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Body temperature increased	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Bronchoscopy	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Liver function test abnormal	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/820 (0%)		2/822 (0.2%)		0/818 (0%)
Hyperglycaemia	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Gout	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Hypercalcaemia	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/820 (0.1%)		3/822 (0.4%)		3/818 (0.4%)
Back pain	3/820 (0.4%)		2/822 (0.2%)		1/818 (0.1%)
Foot deformity	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Spinal column stenosis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Spinal pain	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Arthralgia	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Arthritis reactive	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Lumbar spine stenosis	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Spinal osteoarthritis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Spondylisthesis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/820 (0.1%)		3/822 (0.4%)		6/818 (0.7%)
Adenocarcinoma of colon	0/820 (0%)		2/822 (0.2%)		0/818 (0%)
Breast cancer stage II	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Melanocytic naevus	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Pancreatic neoplasm	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Adenocarcinoma gastric	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Angiolipoma	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Benign neoplasm of thyroid gland	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Bile duct adenocarcinoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Breast neoplasm	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Chronic leukaemia	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Gastric neoplasm	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Gastrointestinal carcinoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Invasive ductal breast carcinoma	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Lung adenocarcinoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Lung neoplasm malignant	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Malignant melanoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Metastatic malignant melanoma	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Metastatic squamous cell carcinoma	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Myeloproliferative disorder	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Uterine cancer	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Nervous system disorders
Transient ischaemic attack	2/820 (0.2%)		2/822 (0.2%)		2/818 (0.2%)
Depressed level of consciousness	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Hydrocephalus	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Intracranial aneurysm	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Radicular syndrome	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Sciatica	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Subarchnoid haemorrhage	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Syncope	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Tension headache	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Carpal tunnel syndrome	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Cerebrovascular accident	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Dizziness	1/820 (0.1%)		0/822 (0%)		2/818 (0.2%)
Ischaemic stroke	3/820 (0.4%)		0/822 (0%)		0/818 (0%)
Lacunar infarction	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Loss of consciousness	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
VIIth nerve paralysis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Renal and urinary disorders
Hydronephrosis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Calculus urinary	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/820 (0%)		2/822 (0.2%)		1/818 (0.1%)
Postmenopausal haemorrhage	0/820 (0%)		2/822 (0.2%)		0/818 (0%)
Uterine prolapse	2/820 (0.2%)		2/822 (0.2%)		1/818 (0.1%)
Cervical dysplasia	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Cystocele	0/820 (0%)		0/822 (0%)		3/818 (0.4%)
Uterine polyp	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Dyspnoea	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Pulmonary embolism	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Sinus polyp	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Allergic bronchitis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Pulmonary mass	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Skin and subcutaneous tissue disorders
Dermititis allergic	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Drug eruption	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Hypersensitivity vasculitis	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Surgical and medical procedures
Cholecystectomy	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Colporrhaphy	1/820 (0.1%)		1/822 (0.1%)		0/818 (0%)
Coronary angioplasty	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Hip arthroplasty	0/820 (0%)		1/822 (0.1%)		0/818 (0%)
Joint arthroplasty	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Knee arthroplasty	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Osteosynthesis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Rectocele repair	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Removal of internal fixation	1/820 (0.1%)		0/822 (0%)		0/818 (0%)
Toe operation	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Vascular disorders
Intermittent claudication	0/820 (0%)		1/822 (0.1%)		1/818 (0.1%)
Aortic dissection	1/820 (0.1%)		0/822 (0%)		1/818 (0.1%)
Essential hypertension	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Hypertension	2/820 (0.2%)		0/822 (0%)		2/818 (0.2%)
Hypertensive crisis	0/820 (0%)		0/822 (0%)		1/818 (0.1%)
Other (Not Including Serious) Adverse Events
	Placebo		BA058 80 mcg (Abaloparatide)		Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	447/820 (54.5%)		492/822 (59.9%)		456/818 (55.7%)
Cardiac disorders
Palpitations	3/820 (0.4%)		42/822 (5.1%)		13/818 (1.6%)
Gastrointestinal disorders
Constipation	42/820 (5.1%)		36/822 (4.4%)		34/818 (4.2%)
Nausea	25/820 (3%)		68/822 (8.3%)		42/818 (5.1%)
Infections and infestations
Influenza	39/820 (4.8%)		52/822 (6.3%)		34/818 (4.2%)
Nasopharyngitis	66/820 (8%)		48/822 (5.8%)		52/818 (6.4%)
Upper respiratory tract infection	63/820 (7.7%)		68/822 (8.3%)		73/818 (8.9%)
Urinary tract infection	38/820 (4.6%)		43/822 (5.2%)		41/818 (5%)
Musculoskeletal and connective tissue disorders
Arthralgia	80/820 (9.8%)		71/822 (8.6%)		70/818 (8.6%)
Back pain	81/820 (9.9%)		69/822 (8.4%)		58/818 (7.1%)
Pain in extremity	49/820 (6%)		40/822 (4.9%)		42/818 (5.1%)
Nervous system disorders
Dizziness	50/820 (6.1%)		82/822 (10%)		59/818 (7.2%)
Headache	49/820 (6%)		62/822 (7.5%)		51/818 (6.2%)
Renal and urinary disorders
Hypercalciuria	74/820 (9%)		93/822 (11.3%)		102/818 (12.5%)
Vascular disorders
Hypertension	52/820 (6.3%)		59/822 (7.2%)		41/818 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.